Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01135953




Registration number
NCT01135953
Ethics application status
Date submitted
2/06/2010
Date registered
3/06/2010
Date last updated
8/12/2010

Titles & IDs
Public title
Methods to Enhance Transcranial Direct Stimulation (tDCS)
Scientific title
Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)
Secondary ID [1] 0 0
HREC09344
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Brain Excitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial Direct Current Stimulation (tDCS)
Treatment: Devices - Transcranial Direct Current Stimulation (tDCS)
Other interventions - Transcranial direct Stimulation (tDCS) and D-cycloserine

Experimental: ARM 1 - CONTROL - Subject given tDCS every day of the week (5 sessions) at 2 mA.

Experimental: Arm 2 - INCREASING - Subjects given increasing intensity during tDCS across the week (Monday 1mA, Tuesday 1.5mA, Wednesday 1.5 mA, Thursday 2 mA, Friday 2mA).

Experimental: ARM 3 - CYCLOSERINE - D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.


Treatment: Devices: Transcranial Direct Current Stimulation (tDCS)
tDCS applied to to motor cortex every weekday (5 sessions), at 2mA ,during 20 minutes.Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).

Treatment: Devices: Transcranial Direct Current Stimulation (tDCS)
tDCS applied to the motor cortex every day of the week during 20 minutes, at 1mA first session, 1.5 mA second and third sessions, and 2mA fourth and fifth sessions, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 30 seconds (to avoid the sensation of a flash).

Other interventions: Transcranial direct Stimulation (tDCS) and D-cycloserine
Transcranial Direct Stimulation applied to the motor cortex every day of the week (5 sessions) at 2mA, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
D-cycloserine, administered orally (capsules), 100 mg, twice a week (Monday and Thursday), prior to the tDCS session.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.
Timepoint [1] 0 0
Pre-treatment, post treatment at minute 0, minute 5, minute 10, minute 15, minute 20, minute 25, minute 30, minute 60, minute 90, minute 120.

Eligibility
Key inclusion criteria
- Male

- Right handed (> 18/20 on the Edinburgh Handedness)

- Aged 18-40
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Mental illness

- General medical illness

- Neurological illness, epilepsy

- Alcohol use above National Health and Medical Research Council (NHMRC) guidelines

- Smokers

- Excessive caffeine intake

- Illicit drug use

- Herbal medication use

- Electronic implant, e.g, cochlear implant, pacemaker

- Musculoskeletal problem in the arm

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute, University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
tDCS has been shown to be an effective treatment for depression. However, tDCS is a
relatively new clinical tool and more needs to be understood about its use. This study hopes
to further the field of knowledge by examining how tDCS should be optimally used. Application
of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this
project, tDCS application will be to the motor cortex as it provides a more ready measure of
excitability. Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to
the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated.
Using a cross-over three-arm design this study aims to investigate whether daily tDCS
administered in increasing intensity across sessions leads to greater and lasting effects on
brain excitability than keeping the intensity at a same dose across the days and whether the
excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the
excitatory effects of a single session of tDCS. This in turn will inform on how to optimize
tDCS for therapeutic applications, e.g treatment of depression. The study hypothesis is that
5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions
will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS
alone. The second hypothesis is that the gradational increases in tDCS intensity over 5
sessions will result in greater motor cortex excitability than 5 sessions of tDCS where
intensity is kept constant across sessions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01135953
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01135953